BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E RIGHT

    MDR report key: 15189339 · Received August 8, 2022

    Report

    Report Number
    0001822565-2022-02307
    Event Type
    Injury
    Date Received
    August 8, 2022
    Date of Event
    July 11, 2022
    Report Date
    October 27, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: REF 00588005017 LOT 64083937 ART SURFACE - NEXGEN ROTATING HINGE KNEE ¿ SIZE E 17MM REF 00598801013 LOT 64231567 STEM EXTENSION- NEXGEN ¿ STRAIGHT REF 00598801215 LOT 64196846 STEM EXTENSION ¿ NEXGEN ¿ STRAIGHT REF 00588001502 LOT 11023955 FEMORAL ¿ NEXGEN ROTATING HINGE KNEE ¿ SIZE E REF 00588005014 LOT 64256366 ART SURFACE ¿ NEXTGEN ROTATING HINGE KNEE- SIZE E 14MM REF 00588000400 LOT 64118706 TIBIAL- NEXGEN ROTATING HINGE KNEE ¿ SIZE 4 REF 00588000410 LOT 64109647 TIBIAL AUGMENT ¿ NEXGEN ¿ SIZE 4 10MM THICKNESS REF 3204 LOT 2961147 STÜHMER/WEBER MEDULLARY PLUG WITHOUT DRAIN, PE, CEMENTED 4/16 REF 3204 LOT 2974514 STÜHMER/WEBER MEDULLARY PLUG WITHOUT DRAIN, PE, CEMENTED 4/16 REF 66017747 LOT 90624788 PALACOS R+G 2X40 REF 66017772 LOT 91810019 PALACOS R+G 1X60 FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2022 - 02308.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4; B5; D4; G3; H2; H3; H4; H6; H10. H6: PROPOSED COMPONENT (ANNEX G) CODE IS MECHANICAL (G04) - FEMUR. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: VALGUS MALPOSITION AFTER IMPLANTATION OF COUPLED KNEE JOINT ONE YEAR AGO AND PERSISTENT ANKLE AND KNEE JOINT COMPLAINTS. NO INTRA-OP COMPLICATIONS/EVENTS. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A CONVERSION TO A ROTATING HINGED KNEE. SUBSEQUENTLY, THE PATIENT HAS EXPERIENCED HYPEREXTENSION AND IS BEING SCHEDULED FOR A REVISION, ON AN UNKNOWN DATE. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION OR PRODUCT IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303038 FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E RIGHT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 11023955

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Other SEE H10 NARRATIVE.